Free 3623 - Federal

Department of Health and Human Services

Food and Drug Administration

FARM INVESTIGATION QUESTIONNAIRE
This questionnaire is used in the domestic and imported survey follow-ups and outbreak source investigations. It was developed by CFSAN and ORA for use on investigations of farms implicated in produce associated outbreaks or farms that grew produce that was found positive for pathogens by FDA testing. Attach forms for reporting additional water souces (Form FDA 3623a) and additional sets of workers (Form FDA 3623b) to the primary Farm Questionnaire.

General Information
Name of Farm Owner: Farm Address: Phone Number: Location of Suspect Fields: 1. Date of Farm visit: 2. Outbreak Name/Location/Number: 3. Implicated Food: 4. Agent in Outbreak: Reservoir(s) for this agent:

5. Planting date for implicated field: 6. Harvest date(s) for implicated field: 7. Interim steps (with dates) between planting and harvest (fertilizing, pesticide applications, irrigation):

8. Other crops/foods raised on this or adjoining fields:

Farm Diagram
9. Obtain or draw a map of the farm layout. Use the farmer's or one you draw to identify any possible sources of contamination on the farm or in close proximity: e.g. slope of the land, type of soil, feedlots, sewage treatment plants, sewage disposal systems/latrines/cesspools, areas that would collect drainage, ponds/streams/ rivers/irrigation ditches, water wells, animal grazing/housing, manure storage/composting, accumulations of trash, waste, debris that would attract pests, housing for people. Attach the map to this report. Take photos to further document the layout. Use a geological survey map or global positioning device to describe the longitude and latitude of the suspect field(s). Take pictures of everything possible related to your investigation.

Weather
10. Were there any unusual weather conditions during the growing or harvesting period e.g. drought, heavy rains, No Yes fog or humidity? ......................................................................................................... Explain:

FORM FDA 3623 (11/05)

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PSC Graphics: (301) 443-1090 EF

Farm Investigation Questionnaire

November 2005

Flooding
11. Was the field exposed to flooding any time during the growing or harvesting period? If yes when in relation to harvest: No Yes

What was the depth? How long did the water cover crops: 12. Could heavy rainfall or flooding have contained or spread sewage, manure or other contaminants? No If yes list the sources and their distance from the farm: Yes

Manure Management
13. Has animal manure been used for fertilizer within the last year?.............................. 14. What kind of animals is the manure from? Cattle Swine Poultry Unknown 15. What/who is the source/supplier? Name: Address: Telephone/Fax: (Investigator: obtain copies of invoices of manure shipments and attach) 16. What were the delivery dates? 17. What were the application dates? 18. Where was the manure stored prior to application? No Yes

19. When is manure applied e.g. before planting (how far), at the time of planting, between planting and harvest?

20. How close to harvest was the last application?

21. Can applied manure blow onto downwind crops? ..................................................... Explain:

No

Yes

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Farm Investigation Questionnaire 22. How is manure applied e.g. topical, side dressing, plowed or disked into the soil?

November 2005

23. How close is manure/compost stored to crop field?

24. Is it covered to prevent drift or contained to prevent runoff (e.g., manure lagoons)? ... The following questions may have to be asked of the manure provider/seller:

No

Yes

No Yes 25. Is the manure composted? ......................................................................................... 26. If manure is composted, for how long and how is the composting managed (e.g., is the manure turned to assure more complete breakdown)?

27. Is manure treated?.................................................................................................... No Yes If yes, how was it treated e.g. composted, heat dried, treated with lime, aged, anaerobic digestion, treated in a waste lagoon?

28. Was the treated manure tested?............................................................................... If yes, what was it tested for and what were the findings?

No

Yes

Animal Management
29. Are farm animals or domestic animals, e.g. cattle, dogs, housed or grazed anywhere near the field? No Yes No Yes 30. Is there a feed lot or dairy farm within 1 mile of the field? .......................................... If yes to either question, what animals and how far away? Describe relevant topography (e.g., animal production uphill from fields)

31. Are there fences to keep them out of crops and away from water sources? .............. 32. Would animal production areas drain into the field or water source? .......................... If yes explain:

No No

Yes Yes

33. What wild animals have been observed in the area e.g. deer and other mammals, reptiles, birds.

34. Describe the number of animals and the frequency that they are in the area.

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Farm Investigation Questionnaire 35. Are they excluded or discouraged in anyway? ........................................................... If so, how? No

November 2005 Yes

36. Is there any evidence of animal feces in the field? .................................................... Explain:

No

Yes

37. Are amphibians or reptiles (e.g. frogs, snakes, alligators) possible sources of contamination in the field or in No Yes agriculture water sources?........................................................................................ If yes explain:

No Yes 38. Are farm animals (e.g. horses, donkeys) used in the fields?..................................... 39. Are Domestic animals intentionally introduced into crop production areas (e.g., for weed or pest control, to No Yes eat residual produce after harvest?) ......................................................................... If yes explain. Include time between animals in production area and subsequent harvest.

40. Are there any relevant health problems in the farm animals? ................................... Explain:

No

Yes

Further follow-up animal health may be required with the farmer that owns the animals.

Sewage Use
41. Is human waste used as fertilizer? ........................................................................... 42. Is sewage (sewage sludge or biosolids) use on this crop? ....................................... If so, where is it from? No No Yes Yes

43. How was it treated e.g. composted, heat dried, treated with lime, aged, anaerobic digestion, treated in a waste lagoon?

44. On what crops are the sludge/biosolids used?

45. How close to harvest was it applied? 46. Is recycled (sewage plant treated) water used? ....................................................... If yes when was it applied? How was it applied? No Yes

No 47. Is grey water e.g. non-human wastewater used for irrigation? .................................. If yes, what is the source of the grey water, how is it applied and how close to harvest is it applied?

Yes

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Farm Investigation Questionnaire

November 2005

Treatments/Fertilizers/Pesticides
48. Are chemical fertilizers used? .................................................................................. 49. How many days prior to harvest were the chemicals applied? 50. What crops are treated with chemical fertilizers? No Yes

51. How is it applied? No 52. Was water used to mix with the chemicals applied? ................................................. If yes what was the source of the water? 53. Are biological treatments used e.g. bees for pollination, mites for competitive exclusion, Bacillus No thuringiensis for pest control? ................................................................................... If yes explain which ones are used, for how long, and how close to harvest.

Yes

Yes

54. Does the farm apply pesticides or herbicides to crops? ........................................... Explain:

No

Yes

55. How are they applied? Truck or tractor mounted spray rig: Airplane Manual spray Other 56. What is the water source used for mixing and applying pesticides? 57. How close to harvest are pesticides applied?

58. Are pesticide mixing tanks, mixing paddles, spray tanks clean? .............................. Explain:

No

Yes

59. Where is pesticide equipment stored when not in use e.g. on ground, protected from contamination?

Harvest Tools and Equipment
60. Harvest method: Bare hand Gloved hand Automated/machine (no hand contact) Explain: Bare hand with utensil (e.g.: knife) Gloved hand with utensil Other

61. What tools are used in harvesting the crop e.g. knives, clippers?

62. Are they designed and constructed to allow for cleaning? ........................................ Explain:

No

Yes

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Farm Investigation Questionnaire Are they clean? .......................................................................................................... Explain: No

November 2005 Yes

63. How are they cleaned and sanitized, by whom and how often?

64. Are re-usable harvest containers used? ................................................................... 65. What materials are they made from? Wood Plastic Cardboard Other 66. How are they cleaned before and during use?

No

Yes

67. How and where are they stored when not in use (e.g., on the ground, in a shed)?

68. How is large crop equipment that comes in contact with edible crops cleaned (e.g. blades, chutes, and conveyors)?

69. Is harvest equipment leased or contracted out? ....................................................... If yes, who is the contractor and what other crops are harvested with this equipment?

No

Yes

70. Answer the equipment design, condition, cleaning and sanitizing questions for this equipment.

71. Is equipment used to haul crops used for other tasks such as hauling garbage, manure? Explain:

No

Yes

72. How is this equipment cleaned prior to use for hauling harvested crops?

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Farm Investigation Questionnaire 73. Are crops washed/processed in the field? .................................................................. Explain: No

November 2005 Yes

Packing Facility
74. Characterize the size of the operation (e.g., number of employees, stability of work force, season of operation):

75. Draw a diagram and flow chart of the packing facility and identify any possible sources of contamination (include location of restrooms, break areas, storage areas for equipment, chemicals, packaging, and personal items). 76. Is the packing equipment designed and constructed and maintained to facilitate cleaning and sanitization? No Yes .................................................................................................................................. Explain:

77. Is the packing equipment cleaned? .......................................................................... Sanitized? ................................................................................................................. If so, how often, using what compounds? Explain:

No No

Yes Yes

78. Does the plant recycle water? .................................................................................. 79. Does recycled water flow go from relatively clean to relatively dirty operations? ..... Explain:

No No

Yes Yes

80. Is the crop cooled? ................................................................................................... How is it cooled (e.g., is a water spray, hydro-cooler, hydro-vac, forced air used)? Explain:

No

Yes

81. Is water with a disinfectant used in the packing facility? ........................................... Where is it used, what chemical, and how much is used?

No

Yes

82. What residual of disinfectant is in the cooling water at the time of inspection? __________ ppm 83. How was the residual measured?

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Farm Investigation Questionnaire 84. How does the operator monitor disinfectant residual in the process water?

November 2005

Are records kept of the test findings? ........................................................................ 85. How and how often is the hydro-cooler cleaned?

No

Yes

86. How and how often is the water changed in the hydro-cooler?

87. How and how often is flume water changed?

88. Measure the temperature of the product immediately before it is washed/processed by water. _______ degrees 89. Measure the temperature of the water when it is used to wash/process produce? _______ degrees Record the location where these temperatures were taken: (For some produce (e.g., tomatoes, celery, apples), it is recommended that the water be 10 degrees F warmer than the product to prevent uptake of the water by the produce.) 90. What is the source of ice used in the packing facility?

91. Is ice produced, stored and used in a sanitary manner? .......................................... Explain:

No

Yes

92. Describe how sewage and wastewater are disposed of.

93. Is there evidence of amphibians, reptiles, insects or other birds inside the packing area? .................................................................................................................................. No Explain, including proximity to product:

Yes

94. What is the temperature of product refrigeration rooms? _________ degrees What is the temperature of product under refrigeration? _________ degrees 95. How long has the product been stored?

Examine the refrigeration rooms for condensate problems, pest control, and cleanliness. Findings:

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Farm Investigation Questionnaire

November 2005

Transportation
96. Are vehicles used to transport produce from the field to the packing facility and from the farm to market also No Yes used to transport animals, manure or other sources of contamination? ................... Explain:

97. Is someone assigned responsibilities for ensuring trucks are: clean and sanitary? No pre-cooled (if appropriate for crop)? No Is someone aware of previous load hauled? No

Yes Yes Yes No Yes

98. Are the transport vehicles cleaned and sanitized prior to being used for produce?..... Explain:

99. Are transport vehicles inspected prior to each use? ................................................. Explain:

No

Yes

100. Are the transport vehicles onsite at the time of inspection clean and sanitary? ....... Explain:

No

Yes

101. Is the product temperature monitored while being transported?...............................

No

Yes

102. How is product temperature monitored in vehicles transporting the produce from farm to market (e.g., do they use temperature monitoring devices)?

Environmental and Product Sampling
Prior to your visit determine whether the samples are for regulatory or epidemiological purposes or both. Determine with laboratory, regulatory and epidemiology consultants what should be sampled (e.g., produce, soil, water, workers, food contact surfaces) prior to visiting the farm. Live animals including invertebrates will not ordinarily be collected. However, if investigators receive a request for collection of live animal samples or decide such collection is necessary, they must notify and obtain concurrence from OCM/OEO, ORO, and CFSAN. Discussions should also cover what tests should be run on samples, who has the expertise to collect and analyze the samples, how the sample findings will be interpreted, and what will be done with positive findings. If surface waters are used for irrigation or other product contact use, use Moore swab tests to identify the pathogen.

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Farm Investigation Questionnaire

November 2005

WATER SOURCES (includes questions 104 through 113)
This section must be completed one time for each water source used for growing, packing, processing or transportation. If there is more than one water source you will need additional copies of this section. · If using MS Word: copy, paste, and complete this section for each additional water source. · If using Adobe PDF: fill out FDA Form 3623a for each additional water source. Also, complete the appropriate forms referenced below for each water source. Date: Name and location of source:

How used (e.g., irrigation, cooling, and pesticide application)?

In addition complete the appropriate forms from "Procedures To Investigate Waterborne Illness ­ Second Edition ­ 1996" International Association of Milk Food and Environmental Sanitarians Inc. Des Moines, Iowa, for each water source: · Form G2 - "Record Review of On-site Investigations and Test Results Prior to and During Outbreak" · Form G3 - "Source and Mode of Contamination of Surface Waters" · Form G4 - "Source and Mode of Contamination of Ground Waters" · Form G5a - "Disinfection Failures That Allowed Survival of Pathogens or Toxic Substances" · Form G5b - "Source of Contamination and Treatment Failures That Allowed Survival of Pathogens or Toxic Substances" · Form G6 - "Sources and Modes of Contamination During Distribution and at Point of Use" 104. Draw a diagram of the water systems using Form G1- "Illustration of Contamination Flow". 105. What are the state, local, regional water quality standards for agricultural water?

106. Does the water used on this farm meet the state standard? .................................... Explain:

No

Yes

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Farm Investigation Questionnaire 107. If this water is used for irrigation, how is it applied (e.g. drip, flood, overhead spray/sprinkler)?

November 2005

108. Does the agricultural water come in contact with the edible portion of the crop? ..... Explain:

No

Yes

109. Has the water been treated? .................................................................................... If so, explain:

No

Yes

110. Has the water been tested for bacterial contamination/indicators?........................... 111. What were the test(s) results?

No

Yes

112. When was the test(s) conducted?

113. What lab did the testing?

Attach a copy of the test report.

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Farm Investigation Questionnaire

November 2005

WORKER HEALTH AND HYGIENE (includes questions 114 through 144)
This section must be completed one time for each set of workers, based on worker type (field or packing facility worker) and location, e.g., field workers at three locations and packing facility workers at two locations would be five sets of workers. If there is more than one set of workers you will need additional copies of this section. · If using MS Word: copy, paste, and complete this section for each additional set of workers. · If using Adobe PDF: fill out FDA Form 3623b for each additional set of workers. Date: Location of workers:

Mark the box indicating the type of workers covered: Field workers Packing Facility workers

Investigators should speak with local/regional medical/public health officials regarding the following questions: 114. What kind of surveillance and reporting are conducted by local/regional public health authorities for the agent in this outbreak?

Investigators should request copies of summary surveillance reports from the local/regional public health authorities for the agent of concern for the past year or two. This will allow for an evaluation of disease trends. 115. Has there been any enteric disease in the farm workers or their families?............... If so, explain what disease(s), and what testing was done: No Yes

116. Do workers seek medical attention when they are ill? .............................................. Explain:

No

Yes

Investigators should encourage firms to work with the local public health agency to have workers with enteric diseases tested for the agent of concern. If the local public health agency collected positive clinical isolates from workers for the agent of concern investigators should collect information available, including contacts that will allow OCM/OEO to coordinate obtaining clinical isolates, for comparison to those of outbreak victims.
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Farm Investigation Questionnaire

November 2005

117. What is the prevalence/incidence of enteric disease in the community and what agents are involved?

118. Are there cases of the disease under investigation among household contacts of workers? No Explain:

Yes

Ask the following questions at the farm and packing facility. 119. Is there health and hygiene training of workers in their own language? ................... Explain: No Yes

120. Is there training in sanitation practices for farm workers in their own language? ...... Explain:

No

Yes

121. Is there supervisory oversight for worker health/hygiene/sanitation? ....................... Explain:

No

Yes

122. What toilet facilities are provided for workers (e.g., pit latrines, portable toilets, flush toilets)? Explain:

123. Does the worker housing area provide toilet facilities? ............................................. and handwashing facilities? ...................................................................................... Explain:

No No

Yes Yes

Are the toilets and handwashing facilities clean and supplied with soap, towels, toilet paper? No Explain:

Yes

124. Is dirty handwash water collected in a waste tank or sewage system? .................... 125. Does dirty handwash water drain on to the ground? ................................................
FORM FDA 3623 (11/05) PAGE 13

No No

Yes Yes

Farm Investigation Questionnaire 126. Are toilet facilities provided convenient for workers in the fields? .............................. Explain: No

November 2005 Yes

Are workers given time to use the facilities as needed? ........................................... 127. Is there any evidence that the toilet facilities are used?............................................ 128. Where are portable field toilets serviced (e.g., emptied)?

No No

Yes Yes

129. Is this done in a way that protects crops from contamination? ................................. Explain:

No

Yes

130. How is the sewage collected from the holding tanks disposed of?

131. Is there evidence of human feces in or adjacent to the fields? ................................. Explain:

No

Yes

132. Are handwashing facilities provided for field workers and are they supplied with water, soap and drying No Yes devices?.................................................................................................................... Explain:

133. Is there evidence that workers use the handwashing facilities after they use the toilet? Explain:

No

Yes

134. Is liquid hand sanitizer used in placed of handwashing? .......................................... Explain:

No

Yes

135. Do workers touch the produce with their bare hands?.............................................. Explain:

No

Yes

136. Do workers wear disposable gloves when touching produce? ................................. Who provides them? Explain:

No

Yes

137. Are there children in the fields? ................................................................................ 138. Do they come in contact with the produce? .............................................................. 139. Do they use toilet facilities versus excreting in the fields? ........................................
FORM FDA 3623 (11/05) PAGE 14

No No No

Yes Yes Yes

Farm Investigation Questionnaire 140. Do they wash their hands? ....................................................................................... Explain: No

November 2005 Yes

141. Are diapers used?..................................................................................................... If so, where are they changed and how are the soiled diapers disposed of?

No

Yes

142. Are worker's clothes, including mothers of small children, worn in the field or packing facility clean? No Yes Explain:

143. Do farm workers or other persons frequent the fields at times when they are not working on the crops (e.g., No Yes is there loitering in the fields by persons who could contaminate the crops?) .......... Explain:

144. Do the field or plant workers have animals at home? ............................................... If yes, do they have any relevant health problems? .................................................. Explain:

No No

Yes Yes

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